Adjustable Tension Incontinence Sling Assemblies

ABSTRACT

Systems for providing support to body tissue to alleviate incontinence are disclosed that comprise an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus and first and second sling end portions extending from the central support portion through body tissue and a tension adjustment mechanism acting on or within one or both of the sling end portions. The sling tension adjustment mechanism is attached to and extends through an adjustment spacing between sling intermediate ends within at least one sling end portion. The adjustment spacing is lengthened to decrease sling tension and shortened to increase sling tension

RELATED APPLICATIONS

This application claims priority to PCT Application No.PCT/US2007/014533 filed Jun. 22, 2007, which claims priority to U.S.Provisional Application Ser. No. 60/805,544 filed Jun. 22, 2006, andU.S. Provisional Application Ser. No. 60/806,664 filed Jul. 6, 2006, theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention pertains to improved methods and apparatusproviding support to a portion of the urethra or rectum or anus toalleviate urinary or fecal incontinence and particularly to elongatedslings having mechanisms for selectively adjusting the tension appliedthrough the sling to body tissue.

BACKGROUND

Urinary incontinence is a condition characterized by involuntary loss ofurine, beyond the individual's control, due to the loss or diminution ofthe ability to maintain the urethral sphincter closed as the bladderfills with urine. Male or female stress urinary incontinence (SUI)occurs when the patient is physically or emotionally stressed. Suchpatients may also experience urge incontinence.

Fecal incontinence is a condition characterized by involuntarydefecation or passage of feces through the anal canal due to injury toor weakness of one or more of the internal anal sphincter, the externalanal sphincter, and the levator ani.

Implantable urethral and anal prosthetic sphincter systems have beendisclosed in the prior art to treat incontinence that comprise aninflatable balloon that is either pillow or cuff shaped, a balloonreservoir/pressure source filled with a fluid, a pump, andinterconnecting tubing. The balloon is implantable beneath orsurrounding the urethral tract (at or near the bladder neck in femalepatients) or around the anal sphincter and is coupled through tubing tothe balloon reservoir/pressure source and pump that are implantedsubcutaneously. The pump may be manually actuated to inflate theballoon, which in turn compresses the urethral tract and preventsincontinence. The balloon may be deflated to allow voiding. Examples ofsuch prosthetic sphincter systems are disclosed in U.S. Pat. Nos.4,222,377, 4,571,749, and 5,562,598, and one such system comprises theAMS-800 Urinary Control System available from American Medical Systems,Inc.

Urethral tapes or slings have been developed that are implanted in aurethral sling procedure in which the urethral sling is inserted beneaththe urethra and advanced in the retro pubic space, perforating theabdominal fascia. In one procedure, peripheral or end portions of theelongated urethral sling are affixed to bone or body tissue, and acentral support portion of the elongated urethral sling extends underthe urethral or bladder neck to provide a platform that compresses theurethral sphincter, limits urethral distention, and pelvic drop, andthereby improves coaptation. Elongated “self-fixating” slings have alsobeen clinically introduced for implantation in the body that do notrequire that the end portions be physically attached to tissue or boneand that rely upon tissue ingrowth into sling pores to stabilize thesling as disclosed, for example, in commonly assigned U.S. Pat. Nos.6,382,214, 6,612,977, 6,641,524, 6,648,921, 6,652,450, 6,702,827,6,802,807, and 6,911,003 and publications and patents cited therein.

The above-described slings comprise a central portion that is adapted tosupport the urethra, two end portions bracketing the support portion, aprotective sheath or sheaths encasing at least the end portions, andconnectors at the ends of the sling. Various ways of attaching a sleeveend and sling mesh end to a connector are detailed in theabove-referenced '450 patent, for example. Further ways of attachingsling ends to sling implantation tools are disclosed in U.S. PatentApplication Publication Nos. 2004/0087970, 2005/0245787, and2005/0250977. The sling implantation tools are employed to form tissuepathways extending from a vaginal incision to two abdominal skinincisions and to draw the sling end portions through the pathways todispose the sling free ends out of the skin incisions and the centralportion around the urethra. The connectors are detached from the slingends, and the sheaths are drawn out of the skin incisions, allowing theincisions to be closed.

Sling tension is typically adjusted at implantation sufficiently to takeup any slack in the sling and impart at least a degree of increasedtension to the urethra with the bladder empty. A surgical instrument maybe placed between the sling central portion and the urethra, the slingends drawn to tension and fully close the urethral tract, and theinstrument withdrawn so that the uethra is relaxed sufficiently tofunction. Alternative tension adjustment mechanisms that may be employedduring implantation are disclosed in the above-referenced commonlyassigned '827 and '921 patents.

Typically, such urethral tapes or slings are fabricated of a loose weavesling fabric or mesh that acutely engages tissue and encourages tissueingrowth along the pathway through mesh pores to achieve chronicstabilization or “self-fixation. Tissue ingrowth takes about 2-3 weeksin the typical patient in the absence of any significant intentional orunintentional movement of the mesh. During this post-operative time, thepatient monitors the degree of success achieved in ameliorating leakageand any discomfort that might occur if the applied tension is so high asto unduly slow voluntary urination.

If any such problems occur, it may be necessary to reopen the incisionsto access and pull on the sling ends to tighten the sling centralportion around the urethra or to reopen the vaginal incision to pull onthe sling central portion to loosen the sling central portion around theurethra. Several approaches have been taken to simplify or reduce theneed for such post-operative adjustments.

One tension adjustment complication arises from the fact that the looseweave sling mesh inherently stretches and elongates when tension isapplied at the ends or central support portion to overcome resistance ofthe tissue bearing against the sling mesh along the tissue pathway. Itis difficult to judge just how much tension to apply to achieve adequatetightening or loosening in the central support portion. In one approachto overcoming this complication disclosed, for example, in theabove-referenced '450 patent, an elongated repositioning means, e.g., anelongated inextensible tensioning member, is incorporated extending inor along the sling mesh from near the sling ends to or through the slingcentral portion. Tension applied to the repositioning means istransmitted along the length of the sling so the sling mesh does notsubstantially stretch during initial positioning and any repositioningduring the acute healing phase.

In another approach disclosed, for example, in U.S. Patent ApplicationPublication 2006/0058574 (FIGS. 4a-4f), an expandable member orcontainer is incorporated on or in the sling central support portionthat can be inflated or deflated with bulking agent to apply more orless tension to the urethra. As stated therein, optionally, thecontainer has a touchable internal valve element to permit the surgeonto palpate the area prior to injecting or removing the bulking agent.Alternatively, the bulking agent may be injected and removed via atwo-way external port. When a bulking agent is injected into thecontainer, the tissue between the mesh and urethra will expand. Thisresults in two effects; a simple vertical lifting due to expansion and avertical lifting due to stretching the outside of the mesh. A suitablebulking agent may be water or saline. A similar approach is disclosed inU.S. Pat. Nos. 4,019,499 and 6,786,861.

Other approaches that enable increasing tension of the sling centralportion against the urethra involve shortening the lengths of the slingend portions as described, for example in the above-referenced, commonlyassigned '921 patent. Mesh folds are formed in the sling end portionsusing filaments that extend through vaginal incisions externally of thebody. Depending on the embodiment, the mesh folds can be released todecrease sling tension or be tightened to increase sling tension bypulling on the filament ends following the initial implantationprocedure. In other embodiments, filaments are extended substantiallythrough the lengths of the sling end portions and extend from thevaginal incisions. The filaments may be gripped and pulled to tightenthe mesh in the sling end portions to increase overall sling tension.

In still another approach disclosed, for example, in U.S. PatentApplication Publication 2006/0058574 (FIGS. 5a-5c), the mesh sling ortape is further modified to include a mechanical adjustment means toadjust the length of the tape in the end portions on either side of thecentral portion after the tape has been implanted in the tissuepathways. The mechanical adjustment means incorporate a tie-wrapmechanism or sutures and one-way suture retaining devices of the typedisclosed in U.S. Pat. No. 5,669,935 located along the tape on eitherside of the central portion. In each case, one suture end is affixed tothe tape and extends along it and through a suture retaining deviceaffixed to the tape closer to the central portion. The sutures ortie-wrap are not tensioned at implantation, and the tie-wrap or suturefree ends extend through the vaginal incision. If the tension on theurethra is too light as determined during the acute healing phase, thesurgeon may grasp and pull on the tie-wrap or suture free ends toshorten the lengths of the tape end portions and thereby increase slingtension. The exposed suture or tie-wrap ends may be severed duringchronic implantation.

In yet another approach, tape or sling ends or the end of a tensioningcable coupled to a urethral support mechanism are coupled to anadjustment mechanism that is chronically implanted subcutaneously andcan be accessed to adjust sling tension. See, for example, commonlyassigned U.S. Pat. No. 4,969,892 and further U.S. Pat. Nos. 5,474,518and 6,117,067 and the REMEEX® readjustable sling by Neomedic, Intl.(www.remeex.com). Ratchet or gear adjustment mechanisms that areaccessed using a driver inserted through the skin and thereby rotated toincrease or decrease sling tension are disclosed in the '892 and '518patents. An inflatable/deflatable elastic chamber, adjustment mechanismthat incorporates a fill port that is penetrable by a syringe needleadvanced through the skin is disclosed in the '067 patent. Theadjustment forces are applied to the sling ends and must be transmittedthrough the sling to effect any change in tension along the slingcentral portion adjacent the urethra.

Further sling tension adjustment mechanisms and techniques involveadding tensioning filaments to the sling free ends and extending theelements through the skin incisions and into engagement with buttons orpads implanted subcutaneously engaging a muscle or rectus fascia layerand/or having tissue engaging elements or anchors along the filament orat the sling ends that engage subcutaneous tissues as disclosed, forexample, in U.S. Pat. No. 6,911,002 and in U.S. Patent ApplicationPublication Nos. 2005/0004576 and 2006/0089525.

Although effective in alleviating SUI, further improvements in urethraland anal slings to post-operatively adjust tension applied to theurethra and anus are desirable.

SUMMARY

The preferred embodiments of the present invention incorporate a numberof inventive features that address the above-described problems that maybe combined as illustrated by the preferred embodiments oradvantageously separately employed.

The present invention involves improvements in an elongated incontinencesling, or simply sling, comprising a central support portion and endportions extending from the central portion to sling ends. Herein, useof the term sling or the expression “incontinence sling” without furtherqualification shall embrace urethral slings adapted to be placed througha tissue pathway disposing the central support portion between theurethra or bladder neck (hereafter collectively referred to as theurethra for convenience) and the vaginal wall to alleviate urethralincontinence and fecal slings adapted to be placed through a tissuepathway disposing the central support portion inferior to the anus, theanal sphincter or the lower rectum (hereafter collectively referred toas the anus for convenience) to alleviate fecal incontinence. Certainembodiments employ tensioning filaments or lines or sutures that arereferred to as sutures for convenience.

In accordance with the present invention, such slings are improved toenhance post-operative sling adjustment of the tension applied to theurethra or anus to enhance efficacy and patient comfort. Severalcategories of the invention are disclosed herein. The variousembodiments disclosed herein are applicable to both males and females,to address issues of incontinence in both, to address issues of prolapserepair in female and perineal floor descent, as well as fecalincontinence in both. Also surgical techniques such as formingsuprapubic, retropubic, transobturator, inside out, outside in tissuepathways between two skin incisions, or a tissue pathway formed from asingle incision through the vagina or perineal floor (in male or femalepatients) are also contemplated for passage of a sling therethrough.

In various embodiments, sling tension adjustment mechanisms joinseparate sling pieces forming part of the sling mesh with the sling endportions such that the sling tension adjustment mechanisms areinterposed between and attached to sling intermediate ends that arespaced apart by an adjustment spacing. Various adjustment actuators andtechniques are employed to adjust the sling tension adjustmentmechanisms to decrease or increase the adjustment spacing between thesling intermediate ends to thereby shorten or lengthen, respectively,the overall length of the sling end portions and to thereby increase ordecrease, respectively, the tension applied by the central supportportion to the urethra or anus. The sling tension adjustment mechanismsare disposed along the sling end portions so as to be disposed at tissuepathway locations that are proximate the patient's skin to enableapplication of the external adjustment actuator against the skin orthrough the skin and underlying tissues to operate the sling tensionadjustment mechanisms.

In one embodiment, sutures are threaded back and forth through meshpores adjacent the intermediate ends and across the respectiveadjustment spacings of each sling end portion. The suture ends areadapted to be extended through the skin incisions to function asadjustment actuators in the manner of draw strings for later adjustmentof the adjustment spacings during the acute healing phase. The sutureends may be grasped and pulled to pull the sling intermediate endscloser together to decrease the adjustment spacing and thereby decreasethe sling length and increase tension applied by the center supportportion to the urethra or anus.

In a variation of this embodiment, the tensioning sutures are passedthrough suture or tissue anchors that engage subcutaneous muscle, therectus fascia or the transobturator membrane and extend through the skinincisions employed to form the tissue pathway that the sling extendsthrough. Alternatively, the tensioning sutures are passed through sutureor tissue anchors that engage subcutaneous muscle, the rectus fascia orthe transobturator membrane and extend through other skin incisions tobe grasped and pulled on to adjust tension. For convenience, suchsubcutaneous muscle, the rectus fascia or the transobturator membrane orother membranes and fascia are collectively referred to as tissue layersherein.

In another embodiment, the external adjustment actuator comprises asignal transmitter that is employed to generate a sling adjustmentcommand that passes transcutaneously (through the intact skin), and theadjustment mechanism comprises a receiver for receiving the transmittedcommands and increases or decreases the adjustment spacing. In yetfurther embodiments, the external adjustment actuator is a magneticfield generator or permanent magnet that is employed to generate amagnetic field representing a sling adjustment command that passestranscutaneously through the skin, and the adjustment mechanismcomprises a magnetic field responsive element that responds byincreasing or decreasing the adjustment spacing. In still furtherembodiments, the sling tension adjustment mechanism comprises atemperature responsive element responsive to heat or cold appliedtranscutaneously by an external thermal heater or cooler to heat or coolthe adjustment mechanism to thereby increase or decrease the adjustmentspacing. In yet further embodiments, the sling tension adjustmentmechanism comprises light responsive elements responsive to certainwavelengths of light that can be generated by an external adjustmentactuator and transmitted transcutaneously to the sling tensionadjustment mechanism to thereby increase or decrease the adjustmentspacing.

In still another embodiment, the external adjustment actuator isinserted percutaneously (penetrating the skin) to engage and operate thesling tension adjustment mechanism to increase or decrease theadjustment spacing. Various sling tension adjustment mechanisms areprovided that can be rotated by the external adjustment actuator in onedirection to draw the sling intermediate ends together to increase slingtension and that can be rotated in the other direction to allow thesling intermediate ends to separate apart to decrease sling tension.

In yet another embodiment, the external adjustment actuator is a syringeor the like that is inserted percutaneously to engage a port of a fluidretaining chamber of the sling tension adjustment mechanism, whereby theadjustment spacing is adjusted by injecting or withdrawing fluid fromthe fluid chamber to increase or decrease the adjustment spacing. Incertain variations, the sling tension adjustment mechanism comprises afluid reservoir to be implanted just below the skin, a fluid chamberdisposed in the adjustment spacing and coupled to the intermediate ends,and a tube extending between the fluid reservoir and the fluid chamberin each sling end portion. The fluid reservoir has a fluiddelivery/withdrawal port that may be percutaneously accessed tointroduce fluid into the fluid reservoir or to withdraw fluid from thefluid reservoir following implantation of the sling to thereby adjustthe amount of fluid in the fluid chamber and adjust the length of theadjustable spacing.

In certain embodiments, the fluid chamber comprises a single actionhydraulic cylinder disposed in the adjustment spacing coupled to onesling intermediate end, the cylinder containing a fluid operated pistonwithin an elongated chamber, the cylinder coupled to a sling adjustmentrod that is in turn coupled to the other sling intermediate end. Thefluid volume introduced into the fluid chamber determines the pistonlocation in the cylinder and the resulting length of the adjustmentspacing. In a variation, a dual action hydraulic cylinder having a pairof opposed pistons in the fluid chamber are each coupled to rods thatare in turn coupled to sling intermediate ends governs the adjustmentspacing.

In these embodiments, the fluid chambers are preferably empty of fluidwhen the sterile sling is supplied in the sterile package from themanufacturer. Implantation of the sling through body pathways may besimpler and easier with the fluid chambers empty. The fluid, e.g., asterile saline or other biocompatible hydraulic fluid, may be introducedthrough the fluid delivery port(s) while the port(s) are stillaccessible. The amount of fluid necessary to effect blockage of theurethral tract may be checked by draining and filling the patient'sbladder through the urethral tract, determining efficacy, and adding orwithdrawing fluid to adjust the applied urethral pressures in thepressurized and ambient pressure fluid distribution states. Similarprocedures may be employed to effect constriction of the anal canal.

In further embodiments the external adjustment actuator comprises anelongated gear drive instrument having a shaft extending between ahandle and an engaging end shaped to be percutaneously advanced throughthe skin. The adjustment mechanism comprises a driven gear meansengageable by the engaging end the gear drive for operating the spacingadjustment means to increase or decrease the adjustment spacing.

Optionally, sling end tissue anchors may be provided on sling ends toengage tissues, e.g., the rectus fascia or the obturator membrane to fixthe sling ends and aid in tension adjustment of the sling end portions.

Optionally, a sling adjustment mechanism may be incorporated into thesling central support portion to enable the separate tensioning of thesling central support portion.

This summary of the invention has been presented here simply to pointout some of the ways that the invention overcomes difficulties presentedin the prior art and to distinguish the invention from the prior art andis not intended to operate in any manner as a limitation on theinterpretation of claims that are presented initially in the patentapplication and that are ultimately granted.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other advantages and features of the present invention will bemore readily understood from the following detailed description of thepreferred embodiments thereof, when considered in conjunction with thedrawings, in which like reference numerals indicate identical structuresthroughout the several views, and wherein:

FIG. 1 is a schematic view of an exemplary sling assembly enclosing asling adapted to be modified in accordance with the invention tofunction as an adjustable tension urethral or fecal sling;

FIG. 2 is a schematic illustration of the sling of FIG. 1 adapted to bemodified in accordance with the invention to provide an adjustabletension function;

FIG. 3 is a schematic illustration of a urethral sling of FIG. 2implanted in a female patient's body in relation to the urethra orbladder neck;

FIG. 4 is a schematic illustration of a fecal sling of FIG. 2 implantedin a female patient's body in relation to the anus and rectum;

FIG. 5 is a schematic illustration of the relation of the sling centralsupport portion and sling end portions to the urethra or anus;

FIG. 6 is a schematic illustration of a generic embodiment of anadjustable tension sling of the present invention having sling tensionadjustment mechanisms formed in gaps or spaces in the sling mesh formingthe sling end portions such that the sling tension adjustment mechanismsare interposed between and attached to sling intermediate ends that arespaced apart by an adjustment spacing;

FIG. 7 is a schematic illustration of the generic embodiment of FIG. 6having optional tissue anchors extending from the sling ends to aid inthe operation of the sling tension adjustment mechanisms;

FIGS. 8 and 9 are schematic illustrations of an embodiment of anadjustable tension sling, wherein sliding locks that engage intermediateends or loops of the sling mesh are incorporated into the sling endportions to increase and/or decrease the sling tension;

FIG. 10 is a schematic illustration of a further embodiment of anadjustable tension sling, wherein sling tension adjustment suturesbridge adjustment spacings in the sling end portions and extend throughthe skin to increase and/or decrease the sling tension;

FIG. 11A is a schematic illustration of a variation of the adjustabletension sling of FIG. 10, wherein the sling tension adjustment suturesextend through or around tissue anchors and extend through the skin tobe available to increase and/or decrease the sling tension;

FIG. 11B is a schematic illustration of a further variation of theadjustable tension sling of FIG. 10, wherein the sling ends incorporatetissue anchors passed through and engaging tissue layers and the tensionadjustment sutures extend through or around further tissue anchors andextend through the skin to be available to increase and/or decrease thesling tension;

FIGS. 12 and 13 are schematic illustrations of further preferredembodiments of an adjustable tension sling having sling tensionadjustment mechanisms bridging adjustment spacings in the sling endportions adapted to be adjusted by commands transcutaneously transmittedfrom an external adjustment actuator to increase and/or decrease thetension applied locally to the urethra;

FIGS. 14-17 are schematic illustrations of further preferred embodimentsof an adjustable tension sling having sling tension adjustmentmechanisms bridging adjustment spacings in the sling end portionscomprising serpentine roller adjustment mechanisms that adjusts thelength of an adjustment spacing in response to an externally appliedcommand;

FIG. 18 is a schematic illustration of a further preferred embodiment ofan adjustable tension sling, wherein the adjustment mechanism isadjusted by an external adjustment actuator comprising an externaladjustment actuator having an engaging end at the end of a shaft adaptedto be percutaneously advanced into engagement with the adjustmentmechanism to adjust the length of an adjustment spacing betweenintermediate sling ends in the sling end portions;

FIG. 19 is a schematic illustration of one embodiment of the slingtension adjustment mechanisms of FIG. 18 employing a rotatable bobbin, afixed catch and detents around the bobbin circumference;

FIGS. 20-22 are schematic illustrations of the adjustment mechanism ofFIG. 19 that adjusts the length of an adjustment spacing in response toan externally applied external adjustment actuator;

FIG. 23 is a schematic view in section of a variation on the embodimentof FIG. 19, wherein the adjustment mechanism housing supports arotatable bobbin surrounded by a fixed detent ring providing anincreased range of adjustments;

FIGS. 24-26 are schematic plan illustrations of a further embodiment ofthe adjustment mechanism of FIG. 18, wherein a dual cam assembly havinga first cam operates to decrease the adjustable spacings from theneutral length illustrated in FIG. 24 to the contracted length of FIGS.25A-25D and a second cam operates to increase the adjustable spacings tothe extended length of FIGS. 26A-26D;

FIG. 27 is a schematic illustration of a further preferred embodiment ofthe adjustable tension sling, wherein the adjustment mechanism isadjusted by an external fluid delivery/withdrawal syringe adapted to bepercutaneously advanced into engagement with a fluid port of theadjustment mechanism to adjust the length of the adjustment spacingbetween intermediate sling ends in the sling end portions;

FIGS. 28-31 are schematic plan side or top views illustrating one,single action, hydraulic cylinder, adjustment mechanism of FIG. 27having a fluid chamber adapted to be filled or be emptied of fluid usingthe syringe of FIG. 27 to adjust the length of the adjustment spacingbetween intermediate sling ends in the sling end portions;

FIGS. 32-36 are schematic perspective, side or top views in partialsection illustrating a further single action, hydraulic cylinder,adjustment mechanism of FIG. 27 having a fluid chamber adapted to befilled or be emptied of fluid using the syringe of FIG. 27 to adjust thelength of the adjustment spacing between intermediate sling ends in thesling end portions;

FIGS. 37-40 are schematic perspective or top views illustrating a stillfurther single action, hydraulic adjustment mechanism of FIG. 27 havinga fluid chamber adapted to be filled or be emptied of fluid using thesyringe of FIG. 27 to adjust the length of the adjustment spacingbetween intermediate sling ends in the sling end portions;

FIG. 41 is a schematic illustration of a further preferred embodiment ofthe adjustable tension sling, wherein the adjustment mechanism isadjusted by an external fluid delivery/withdrawal syringe adapted to bepercutaneously advanced into engagement with a fluid port of asubcutaneously implantable fluid reservoir coupled to the adjustmentmechanism to adjust the length of the adjustment spacing betweenintermediate sling ends in the sling end portions;

FIGS. 42-44 are schematic perspective views in partial sectionillustrating a single action, hydraulic cylinder, adjustment mechanismsof FIG. 41 having fluid chambers adapted to be filled or be emptied offluid using the syringe of FIG. 41 to adjust the length of theadjustment spacing between intermediate sling ends in the sling endportions;

FIG. 45 is a perspective view in partial section of a further singleaction, hydraulic cylinder, adjustment mechanism adapted to be employedas depicted in FIG. 41 having fluid chamber portions adapted to befilled or be emptied of fluid using a syringe to add or withdraw fluidfrom subcutaneously implanted fluid reservoirs coupled to the fluidchamber portions to adjust the length of the adjustment spacing betweenintermediate sling ends in the sling end portions;

FIG. 46 is a perspective view in partial section of a dual action,hydraulic cylinder, adjustment mechanism adapted to be employed asdepicted in FIG. 41 having fluid chamber portions adapted to be filledor be emptied of fluid using a syringe to add or withdraw fluid fromsubcutaneously implanted fluid reservoirs coupled to the fluid chamberportions to adjust the length of the adjustment spacing betweenintermediate sling ends in the sling end portions;

FIGS. 47 and 48 are schematic plan views in partial section illustratingone form of locking mechanism incorporated into the single actionhydraulic cylinder adjustment mechanism of FIGS. 28-31;

FIGS. 49 and 50 are schematic plan views in partial section illustratinganother form of locking mechanism incorporated into the single actionhydraulic cylinder adjustment mechanism of FIGS. 28-31;

FIG. 51 is a schematic Illustration of a miniaturized, single action,hydraulic cylinder, adjustment mechanism incorporating the lockingmechanism illustrated in FIGS. 47 and 48;

FIG. 52 is a side plan view of the miniaturized, single action,hydraulic cylinder, adjustment mechanism of FIG. 51;

FIG. 53 is a top plan view in partial section of the miniaturized,single action, hydraulic cylinder, adjustment mechanism of FIG. 51;

FIG. 54 is a schematic Illustration of a miniaturized, mechanical gear,adjustment mechanism that is adjusted by a gear drive extendedtemporarily through the patient's skin;

FIG. 55 is a schematic expanded view in partial section illustrating thegear drive components within the adjustment mechanism of FIG. 54;

FIG. 56 is a schematic Illustration of a further miniaturized,mechanical gear, adjustment mechanism that is adjusted by a gear driveexternal adjustment actuator extended percutaneously through thepatient's skin to engage the gear drive and adjust sling tension;

FIG. 57 is a schematic Illustration of a still further miniaturized,mechanical gear, adjustment mechanism that is adjusted by a rack andpinion gear drive extended temporarily through the patient's skin; and

FIGS. 58A-58D are schematic views in partial section illustratingadjustment of sling tension through use of the rack and pinion geardrive extended temporarily through the patient's skin to adjust theminiaturized, mechanical gear, adjustment mechanism of FIG. 57.

The drawing figures are not necessarily to scale.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The various embodiments of the present invention are implemented inslings suitable for and methods of implanting such slings in thetreatment of male and female urinary and fecal incontinence and toeffect pelvic floor, perineal floor, and pelvic proplapse repairsemploying a variety of surgical approaches. For example, female pelvicfloor repair slings may be implanted by techniques that involvetransvaginal, transobturator, suprapubic, pre-pubic, or transperinealexposures or pathways, and male urinary incontinence slings may beimplanted by techniques that involve transobturator, suprapubic, ortransperineal pathways. Any of the disclosed embodiments can be used asfecal incontinence slings which may be implanted by techniques thatinvolve transvaginal, transobturator, suprapubic or via perineal floorpathways. In fecal incontinence applications, the disclosed embodimentscan be used to correct the anorectal angle in the rectum to re-establishcontinence in patients. The above methods can, but are not necessarilylimited to, utilize helical needles of the type described in U.S. Pat.No. 6,911,003 or C-shaped needles or elongate needles of the type usedto perform suprapubic procedures.

Referring to FIG. 1, an exemplary embodiment of an elongated slingassembly 10 is depicted in which the embodiments of the presentinvention may be advantageously implemented. The elongated slingassembly 10 contains a sling 20 that may be implanted in any of theabove-described manners and pathways pathways through which at least endportions of the elongated sling assembly 10 is drawn to dispose acentral support portion 40 of sling 20 in operative relation to theurethral or bladder neck or around the anal sphincter or elsewhere inthe pelvic region. The sling assembly 10 comprises the sling 20 coupledto sling end connectors 12 and 14 and encased in protective sheaths 22and 24.

The depicted exemplary sling assembly 10 thus extends between sling endconnectors 12 and 14 that engage with the free ends of right hand andleft hand sling implantation tools of the types described above, forexample. The sling end connectors 12 and 14 are shaped to dilate theright and left passages or pathways through body tissue formed by thecurved needles of the right and left hand implantation tools in theabove-described trans-vaginal or transobturator procedures, for example.

In this example, the sling 20 is enclosed within protective sheaths 22and 24 extending from the sling end connectors, 12 and 14, respectively,to respective free and open sheath ends 26 and 28. Preferably, theprotective sheaths 22 and 24 are constructed of a flexible thintransparent plastic film that enables visual examination of the sling 20and is sufficiently lubricious that it passes easily through the tissuepathways of the patient formed using the right hand and left hand slingimplantation tools of the types described above or otherwise created.The sheaths 22 and 24 can include sheath indicia or tear scores,perforations or holes for assisting the surgeon in properly orientingsling 20 relative to the urethra. Embodiments of the present inventionare contemplated that involve modifying the sheaths 22 and 24.

The sling 20 that is left in place chronically (following implantationand removal of sheaths 22 and 24 and end connectors 12 and 14) comprisesan elongated, rectangular (in this depicted embodiment) braided orpreferably knitted, mesh strip or simply mesh 30 as shown in FIG. 2. Thesling 20 and mesh 30 are subdivided into a central support portion 40that is adapted to be placed through a pathway extending between theurethra or bladder neck and the vaginal wall. Proximal end portions 42and 44 of sling 20 extend from the central support portion 40 to themesh ends 32 and 34. In FIGS. 1-5, the mesh 30 extends between mesh ends32 and 34 and may be continuous throughout the length of the sling 20between mesh ends 32 and 34. However, it will be understood that thecentral portion 40 of sling 20 may be formed of other materials suchthat the central portion 40 is physically attached to the end portions42 and 44. In certain embodiments, the central portion 40 may be formedof any tissue-compatible synthetic material or any natural biocompatiblematerial, including, but not limited to, treated autologous, allograft,or xenograft tissues, procine dermis, a tissue engineered matrix, or acombination thereof.

The sling 20 of sling assembly 10 is therefore similar to those thedisclosed in the above-referenced '450 and '003 patents but is modifiedherein to incorporate one or more of the aspects of the presentinvention. It will be understood that the mesh 30 may be dimensionedshaped in a variety of ways known in the art for implantation in thetreatment of male and female urinary and fecal incontinence and toeffect pelvic floor, perineal floor, and pelvic proplapse repairsemploying a variety of surgical approaches. For example, the sling 20may comprise more than two end portions 42 and 44 coupled to connectorsand extending at a variety of angles from a particularly shaped centerportion 40.

In the implantation procedures described in the above-referenced '214,'450, and '524 patents and U.S. Patent Application Publication Nos.2005/0043580 and 2005/0065395, the sling connector ends 12 and 14 arefitted to the implantation tools and the proximal end portions 42 and 44are drawn through the body passageway or pathway. The central supportportion 40 is adapted to drawn against tissue to support the urethra orbladder neck or the anal sphincter or elsewhere in the pelvic regionafter the proximal end portions 42 and 44 are drawn through bodypathways. The sling connector ends 12, and 14 are drawn out of the skinincision and detached from the implantation tool needle ends. The mesh30 and sheaths 22 and 24 are severed just proximate to the connectorends 12 and 14, respectively. The remaining portions of the protectivesheaths 22 and 24 are withdrawn over the mesh 30 and through the skinincisions. The sling 20 then remains in place, and tension adjustmentsare made to provide sufficient urethral or anal resistance to leakage.The incisions are closed upon completion of the tests, and tissueingrowth into the pores of the mesh 30 takes place in a matter of weeks.

Before describing the embodiments of the invention, attention isdirected to a step illustrated in FIG. 3 of one such sling implantationprocedure that results in the sling 20 extending through a tissuepathway created in a female (for example) patient 50 extending aroundthe urethra 58. In preceding steps, the tissue pathway was formed bypassing needles through a vaginal skin incision 62 just adjacent to thevagina 60 through soft tissue between urethra 58 and vagina 60 and alongeach side of urethra 58 through layers of fat, muscle, and fascia andbetween pubic bone 54 and bladder 56 to first and second skin incisionsthrough skin 52. Any of the known tissue pathways may be formed in thisgenerally described manner. In a related embodiment, a sling isimplanted via a single incision (vaginal incision 62) with the slingbeing pushed up into the transobturator or retro pubic space. The endconnectors 12 and 14 of the sling assembly 10 were attached to the sameor other needles to draw the sling assembly 10 through the tissuepathway to dispose the end connectors outside the patient's skin 52. Asshown in FIG. 3, the connectors 12 and 14 and sheaths 22 and 24 wereremoved after being drawn out of the skin incisions, leaving the sling20 in place. In a related embodiment, connectors 12 and 14 areeliminated.

Referring to FIG. 4, a schematic illustration of an incontinence slingimplanted in a female (for example) patient's body for treating fecalincontinence is depicted. In this illustration, the sling centralportion 40 extends underneath the anus or anal sphincter 67 or inferiorportion of the rectum 65 (hereafter collectively referred to as the anus67 for convenience) to correct the anorectal angle in the patient.Various surgical approaches can be used to implant sling 20 to correctfecal incontinence including suprapubic, transobturator, retropubic,prepubic, transperineal and transvaginal (including a single incisionapproach transvaginally or transperineally).

At this point, the tension T that sling 20 applies against the urethra58 or anus 67 is adjusted as schematically illustrated in FIG. 5. Sincethe procedure may be performed using a local anesthesia, the patient 50is able to provide feedback to the surgeon during adjustment of slingtension. In the procedure illustrated in FIG. 3, typically, the bladder56 is filled with saline using a catheter, and the patient is requestedto cough. The surgeon is able to determine whether leakage occurs andmay adjust the tension on the sling 20 by pulling on the exposed slingends 32 and 34 to increase tension of the center support portion 40against the urethra 58 or by pulling on center support portion throughthe vaginal incision to decrease the tension of the center supportportion 40 against the urethra 58. The exposed end sections of the endportions 42 and 44 are trimmed away, and the abdominal incisions and thevaginal incision (as well as the labia fold incisions for thetransobturator approach) are closed. In the various embodiments of thepresent invention, such slings as sling 20 are improved to enhancepost-operative sling adjustment of the tension T applied to the urethra58 or the anus 67 to enhance efficacy and patient comfort.

While not essential to the practice of the present invention, it may bedesirable to provide mechanisms incorporated into or that act on thesling central support portion 40 to facilitate the adjustment of thetension T applied to the urethra 58 or the anus 67. For example, a slingcentral portion adjustment mechanism may be provided to increase and/ordecrease the tension applied locally to the urethra 58 or the anus 67.The sling central portion adjustment mechanism is associated directly orindirectly with the sling central support portion 40 and is distinctfrom the sling tension adjustment mechanisms incorporated in the slingend portion or portions.

For example, as shown in FIG. 10, the sling central portion tensionadjustment may simply comprise a suture 108 extending around the slingcentral portion and passing through the skin incision to providepost-operative tension adjustment of the sling central portion 40 bypulling on sling ends 106. Adjustments may be made until the suture iswithdrawn through the skin 52 or is absorbed by the body.

Longer-term post-operative adjustment of the sling central portiontension may be accomplished with sling central portion adjustmentmechanisms that remain in place. In one approach, the mechanism may beaccessed for tension adjustment employing an external adjustmentactuator that is percutaneously advanced through the skin 52 to engagethe sling central portion adjustment mechanism. For example, one suchapproach involves injecting or withdrawing fluid from a fluid chamber ofa pillow of the sling central portion adjustment mechanism applyingpressure to the urethra 58 or the anus 67.

In certain more complex embodiments of the second category, slingtension adjustment mechanisms are formed in gaps in the sling meshforming the sling end portions such that the sling tension adjustmentmechanisms are interposed between and attached to sling intermediateends that are spaced apart by an adjustment spacing. Various mechanismsand techniques are employed to adjust the sling tension adjustmentmechanisms to decrease or increase the adjustment spacing between thesling intermediate ends to thereby shorten or lengthen, respectively,the overall length of the sling end portions and to thereby increase ordecrease, respectively, the tension applied by the central supportportion to the urethra. The sling tension adjustment mechanisms aredisposed along the sling end portions so as to be disposed at tissuepathway locations that are proximate the patient's skin to enable accessto or application of the external adjustment actuator against the skinor through the skin and underlying tissues to operate the sling tensionadjustment mechanisms.

Turning to FIGS. 6 and 7, in accordance with embodiments of the presentinvention, a sling tension adjustment mechanism is incorporated into oron a section of one or preferably both of the sling end portions 42 and44 proximal to but spaced from the central support portion 40 that canbe adjusted at least in the acute post-operative healing phase. A firstsling end portion tension adjustment mechanism 102 is schematicallydepicted extending between and coupled to sling intermediate ends 36 and38 of sling end portion 42. The gap or adjustment spacing 162 betweensling intermediate ends 36 and 38 is shortened to increase tension orlengthened to decrease tension in sling end portion 42 Similarly, asecond sling end portion tension adjustment mechanism 104 isschematically depicted extending between and coupled to slingintermediate ends 46 and 48 of sling end portion 44. The gap oradjustment spacing 164 between sling intermediate ends 46 and 48 isshortened to increase tension or lengthened to decrease tension in slingend portion 44. The spacing of each sling tension adjustment mechanism102 and 104 from the central support portion 40 is selected in relationto the anatomy for either male or female fecal or urinary incontinenceslings and the implantation route or technique to facilitate access orengagement with an externally applied adjustment actuator or an actuatorelement extending percutaneously from a skin incision. The adjustmentmechanisms are generally adjusted to adjust the length and/or tension ofthe end portions 42 and 44 to thereby tension the center support portion40 and draw it closer to the urethra 58 or anus 67 to relax tension ofthe center support portion 40 to release pressure on the urethra 58 oranus 67.

As shown in FIG. 7, it may be desirable to stabilize the sling ends 32and 34 in tissue by optionally providing sling tissue anchors 92 and 94extending from the sling ends 32 and 34. The anchors 92 may take any ofthe forms disclosed in the above-referenced U.S. Patent ApplicationPublication No. 2005/0004576, for example. Generally speaking suchtissue anchors 92 and 94 can be readily drawn through tissue in thedirection away from the sling ends 32 and 34, respectively, but resistretraction back through the tissue. Advantageously, the sling tissueanchors 92 and 94 may be extended through and bear against the rectusfascia or the transobturator to stabilize the sling ends 32 and 34 toset sling tension and to resist being drawn toward the sling tensionadjustment mechanisms 102 and 104 when tension is increased.

In certain particular embodiments of the invention depicted in FIGS. 8and 9, the end portion tension adjustment mechanisms comprise slidinglocks 132 and 134 (FIG. 8) or 142 and 144 (FIG. 9) that engage the endportions 42 and 44 of the sling mesh 30. In one variation shown in FIG.16, sections of the sling mesh 30 are looped and passed through channelsof sliding locks 132 and 134. In the other variation shown in FIG. 9,the sling intermediate ends are drawn through channels of the slidinglocks 142 and 144. It will be understood that the depicted slings 20 aredisposed in the patient's body the manner depicted in FIG. 3 or FIG. 4.The loops 136, 138 or free ends 146, 148 function as actuator elementsthat can be grasped through the skin incisions 82 and 84 (or through avaginal incision if a single incision approach is chosen) and pulledupon with respect to the sliding locks 132, 134 or 142, 144 to shortenthe lengths of the end portions 42, 44 and increase tension on theurethra 58.

Sliding locks 132, 134 and 142, 144 operate similar to zip-tie locks. Itwill be understood that the depicted loops 136, 138 and the free ends146, 148 can comprise sutures or zip-lock tapes fastened to intermediateends of the sling mesh 30 so that the sutures or zip-lock tapes aredrawn through channels of the sliding locks 132, 134 and 142, 144.

A further specific embodiment of the present invention is depicted inFIG. 10, wherein the end portion 42 is severed at intermediate ends 36and 38 to form a gap or adjustment spacing 162, and the end portion 44is severed at intermediate ends 46 and 48 to form a gap or adjustmentspacing 164. Sutures 156 and 158 are threaded back and forth throughmesh pores adjacent the intermediate ends 36, 38 and 46, 48,respectively, and across the respective adjustment spacings 162 and 164,to function as draw strings for later adjustment of the adjustmentspacings 162 and 164 during the acute healing phase. The suture 156 andadjustment spacing 162 comprise sling end portion tension adjustmentmechanism 152 of end portion 42, and the suture 158 and adjustmentspacing 164 comprise sling end portion tension adjustment mechanism 154of end portion 44.

In this embodiment, the suture ends 166 and 168 of respective sutures156 and 158 extending from the skin incisions 82 and 84 duringimplantation of the sling 20 function as the adjustment actuators. Thesuture ends 166 and 168 may be grasped and pulled to shorten theadjustment spacings 162 and 164 to thereby shorten the sling endportions 42 and 44 and thereby decrease the sling length and increasetension applied by the center support portion 40 to the urethra 58 (oranus).

A further adjustment suture 108 (optionally formed of biodegradablematerial) is optionally placed around the sling mesh 30 and extendedthrough the vaginal skin incision 62 to enable manual tensionadjustment. The suture ends 106 may be grasped and pulled to function asan actuator element and pull the sling mesh away from the urethra 58 torelease tension applied by the center support portion 40 to the urethra58 (or anus).

In the absence of adjustment suture 108, the sling central supportportion 40 may be accessed by reopening the vaginal incision 62 to pullon the sling 20 to draw the sutures 156 and 158 back through the meshpores, thereby increasing the sling length and decreasing tensionapplied by the center support portion 40 to the urethra 58 (or anus).

Optionally, a biodegradable sheath may be placed over the adjustmentmechanisms 152 and 154 and at least a portion of the sling mesh toinhibit tissue ingrowth into the mesh pores and adjustment spacings 162and 164 and thereby ease adjustment of the sling 20 until the sheath isabsorbed and tissue ingrowth encapsulates and immobilizes sling mesh 30.

The suture ends 166, 168, and 106 may be severed at the respectiveincisions 82, 84, and 62 following final adjustment.

Certain sling implantation procedures for urethral and fecal slingsinvolve employing implantation instruments having needles that areadvanced from a first skin incision to a second skin incision to formfirst and second or right and left (non-suprapubic) tissue pathwaysaround the urethra 58 or the anus 67. The instruments or otherinstruments are then employed to push or pull the sling end portions 42and 44 through the first and second pathways to dispose the sling endsnear or through the skin incisions 82 and 84 as shown in FIGS. 3 and 4.The above-described embodiments contemplate implantation in such tissuepathways.

Other sling implantation procedures for urethral and fecal slings havesling ends configured to engage sling implantation tool needle ends tobe pushed from a single incision adjacent the urethra 58 (or the anus67) through first and second tissue pathways to dispose the sling endportions extending away from the urethra 58 (or anus 67). The skinincisions 82 and 84 are not necessarily made, and the sling ends aredisposed at subcutaneous locations.

In a variation of this embodiment of the invention depicted in FIG. 11A,the sutures 156 and 158 are drawn through tissue anchors 96 and 98 thatare passed through and bear against subcutaneous tissue layers 72 and74, respectively. Generally speaking, the tissue anchors 96 and 98 havechannels or bores that one or both of the sutures 116 and 118 are passedthough that grip the sutures with sufficient force to maintain slingtension. The suture retaining force may be overcome by manipulation ofthe suture and tissue anchor to increase or decrease sling tensionduring post-operative recuperation. The suture ends extending throughthe skin incisions 82 and 84 are placed under the skin 52, and theincisions are closed. During chronic implantation, adjustments of slingtension may take place by reopening the skin incisions 82 and 84 toaccess the suture ends and the tissue anchors 96 and 98.

In this embodiment, the suture 156 passes through a slidable bore of thetissue anchor 96 and through the same skin incision 82 that the tissuepathway is created for the sling 20. Similarly, the suture 158 isdepicted extending through a slidable bore of the tissue anchor 98 andthrough the same skin incision 84 that the tissue pathway is created forthe sling 20. For example, the tissue pathway may extend through theright and left transobturator membranes (tissue layers 72 and 74) thatthe tissue anchors 96 and 98 are passed through and bear against.

In a further variation of this embodiment of the invention depicted inFIG. 11B, tissue anchors 632 and 634 are coupled to the sling ends 32and 34, respectively, and the sutures 156 and 158 are passed through thetissue anchors 96 and 98. In the implantation procedure, the tissueanchor 632 and the sling end portion 42 are pushed from a single skinincision below the urethra 58 or anus 67 through a first tissue pathwaysuch that the tissue anchor 632 is passed through and bears againsttissue layer 72. Similarly, the tissue anchor 634 and the sling endportion 43 are pushed from the skin incision below the urethra 58 oranus 67 through a second tissue pathway such that the tissue anchor 634is passed through and bears against tissue layer 74.

The suture 156 and tissue anchor 96 are pushed through a further tissuepathway such that the tissue anchor 96 is passed through and bearsagainst a separate tissue layer 76 and then through a skin incision 86.Similarly, the suture 158 and tissue anchor 98 are pushed through afurther tissue pathway such that the tissue anchor 96 is passed throughand bears against a separate tissue layer 76 and then through a skinincision 88. Alternatively, the sutures 156 and 158 can first be passedby themselves through the skin incisions 86 and 88, respectively, andthe tissue anchors 96 and 98 can be applied over the sutures 156 and 158to bear against the tissue layers 76 and 78, respectively. In a relatedembodiment, the various sling embodiments can be used without tissueanchors.

Tension can be applied by pulling on the suture ends of sutures 156 and158, respectively while applying pressure against the subcutaneoustissue anchors 96 and 98, thereby decreasing the spacings 162 and 164.Tension on sutures 156 and 158 can be release to lengthen spacings 162and 164 by exposing and manipulating the tissue anchors 96 and 98.

It will be understood that the tissue layers 72, 74, 76, and 78 maycomprise a muscle layer, fascia or transobturator membrane. Tissuelayers 72 and 76 may be the same or a different tissue layer, and tissuelayers 74 and 78 may be the same or a different tissue layer. Theparticular locations of skin incisions 86 and 88 and the respectivetissue anchors 96 and 98 may include obturator, abdominal, pelvic,perineal and rectal regions.

The tissue anchors 632, 634, 96, and 98 may take any of the formsdisclosed in the above-referenced '002 patent and in U.S. PatentApplication Publication Nos. 2005/0004576 and 2006/0089525.

A wide variety of other specific embodiments of the invention employingadjustment mechanisms bridging a gap between the sling intermediate ends36, 38 and 46, 48 to adjust spacings 162 and 164 are contemplated. Inthe following embodiments, the adjustment actuator acts upon the slingend portion adjustment mechanisms 102 and 104 by percutaneous directaccess to an adjustment tool or transcutaneous transmission ofadjustment commands to an adjustment control of the adjustmentmechanism. In these embodiments, both shortening and lengthening of thelength of the adjustment spacings 162 and 164 for increasing anddecreasing sling tension are contemplated by these embodiments.

Referring to FIG. 12, adjustment mechanism 202 is disposed across theadjustment spacing 162 and affixed to sling intermediate ends 36 and 38,and adjustment mechanism 204 is disposed across the adjustment spacing164 and affixed to sling intermediate ends 46 and 48. An externaladjustment actuator 200 is depicted brought into proximity to or appliedagainst the skin 52 for generating an adjustment command 210 that iscommunicated transcutaneously through the skin 52 and underlying fat,tissue and fascia to adjustment mechanism 204. It will be understoodthat the external adjustment actuator 200 may also be brought intoproximity to the skin 52 for generating a similar adjustment commandcommunicated transcutaneously through the skin 52 and underlying fat,tissue and fascia to adjustment mechanism 202. The adjustment mechanisms202 and 204 comprise electro-mechanical systems or elements or materialsthat respond to the transmitted command 210 to effect the adjustment inlength of the adjustable spacings 162 and 164. In a related embodiment,mechanisms 202 and 204 are shape memory alloy (e.g. nitinol) elementsthat contract in size and expand in size depending on the stimulus.

In one variation of this embodiment depicted in FIG. 13, the externaladjustment actuator 200 is an RF signal generator that generates an RFsignal 210 through antenna 206 applied to the patient's skin as command210. The adjustment mechanisms 202 and 204 each incorporate an RFantenna 216 that receives the RF signal and apply the received signal tointernal electro-mechanical drive mechanism 218 for extending orcontracting the length of the adjustment mechanisms 202 and 204.

Alternatively, the RF signal 210 is a power signal that is received byantenna 216 to generate a current that is applied to resistive heatingelements or heat responsive elements forming the electro-mechanicaldrive mechanism 218 of each of adjustment mechanisms 202 and 204. Forexample, the electro-mechanical drive mechanism 218 of the adjustmentmechanisms 202 and 204 may comprise chambers holding a heat responsivefluid that expands as heat is applied, and the expanded fluid drivespistons in the chambers to increase the overall length of the adjustmentmechanisms 202 and 204. Or, the electro-mechanical drive mechanism 218may comprise a heat responsive bi-metal strip that is heated by thereceived current and expands or contracts in length to expand orcontract the length of the adjustment mechanisms 202 and 204.

Alternatively, the external adjustment actuator 200 generates a pulsedor steady magnetic field as the command 210. The adjustment mechanisms202 and 204 incorporate magnetic responsive switches, e.g., reedswitches or MAGFETs within the electro-mechanical drive mechanism 218that switch states and operate the electro-mechanical drive mechanism218 to extend or contract the length of the adjustment mechanisms 202and 204.

Alternatively, the external adjustment actuator 200 is simply a heatingor chilling pad that is applied to the skin to locally heat or cool theunderlying tissue and the adjustment mechanisms 202 and 204 to expand orcontract a heat responsive element or material that is incorporated intothe adjustment mechanisms 202 and 204. The heating and/or cooling of theheat responsive element or material extends and/or or contracts thelength of the adjustment mechanisms 202 and 204.

Alternatively, the sling tension adjustment mechanisms 202 and 204comprise light responsive elements, and the external adjustment actuator200 comprises a light source (laser or diode) that emits light pulses ofa light frequency capable of penetrating the skin and underlying fatlayers and fascia as the command 210 that the light responsive elementsare capable of detecting. An electro-mechanical drive mechanism 218responds to the output signals of the light detectors to adjust thelength of the adjustment mechanisms 202 and 204.

FIGS. 14-17 are schematic illustrations of a serpentine roller that maybe incorporated into the adjustment mechanisms 202 and 204 to adjust thelength of the adjustment spacings 162 and 164. The intermediate ends 36,38 and 46, 48 are attached to ends of a band 230 that extends through achannel 226 of the housing 220, the channel 226 including two chambers222 and 224. The band 230 extends around roller 232 disposed in chamber222 and roller 234 disposed in chamber 224. The lengths of theadjustment spacings 162, 164 depend on the location of the rollers 232and 234 in the respective channels 222 and 224.

A maximum length of the adjustment spacings 162, 164 is obtained withthe rollers 232 and 234 disposed substantially out of the respectivechannels 222 and 224 as shown in FIG. 16. A minimum length of theadjustment spacings 162, 164 is obtained with the rollers 232 and 234disposed fully within the respective channels 222 and 224 as shown inFIG. 17. An intermediate or neutral length of the adjustment spacings162, 164 is obtained with the roller 232 disposed fully within therespective channels 222 and the roller 234 disposed substantially out ofthe respective channel 224 as shown in FIG. 15. The sling 20 would beimplanted with the rollers 232 and 234 disposed in the neutral positionof FIG. 15, and later adjustments to the position of FIG. 16 or FIG. 17would be made with an external adjuster applied to the patient's skin52. It is contemplated that movement of the rollers 232 and 234 would becontrolled by an electro-mechanical interface between the rollers 232and 234 and any mechanism responsive to commands 210 generated by theexternal actuator 200 as described above.

In further embodiments illustrated schematically in FIG. 18, theexternal adjustment actuator 310 has an actuator-engaging end 312 at theend of a shaft 314. The tension adjustment mechanisms 302 and 304 areshaped with actuator end receptacles 306 and 308, respectively, that canbe manually palpated through the skin 52. The actuator engaging end 312and shaft 314 can be inserted percutaneously through skin incisions 64and 66 to fit the actuator engaging end 312 into the actuator endreceptacles 306 and 308. The external adjustment actuator 310 isdepicted in engagement (at separate times) with both actuator endreceptacles 306 and 308 in FIG. 18. Various rotatable mechanisms withinthe tension adjustment mechanisms 302 and 304 are contemplated that canbe rotated by manual rotation of the external adjustment actuator 310 inone direction to shorten the sling end portions 42 and 44 together toincrease sling tension and that can be rotated by manual rotation of theexternal adjustment actuator 310 in the other direction to lengthen thesling end portions 42 and 44 to separate apart to decrease slingtension. The actuator engaging end 312 is shaped to both penetratetissue and to have mating surfaces for engaging the end receptacles 306and 308 to enable rotation in both directions.

The tension adjustment mechanisms 302 and 304 depicted in FIGS. 19-22each comprise a bobbin 316 mounted for rotation in a receptacle of ahousing 320 fixed at one end to the sling intermediate end 36, 46, thebobbin 316 shaped with the actuator end receptacles 306, 308 extendingaxially into one side of the bobbin 316. A band or strand 330 extendsfrom a fixed connection with the other sling intermediate end 38, 48into a channel 322 in housing 320 and around a groove of the bobbin 316to a fixed coupling with the bobbin 316. The bobbin 316 is formed withthree detents 332, 334, 336 spaced apart around its circumference, andthe free end of a catch 324 fixed at its other end to housing 320engages one of the detents 332, 334, 336.

In this embodiment, the actuator end receptacles 306, 308 have a fivesided socket shape, and the engaging end 312 of the shaft 314 ofexternal adjustment actuator 310 is also shaped as a mating five-sidewrench having a distal point and is shown poised to be inserted into theactuator end receptacle 306, 308 in FIG. 19. The neutral position of thebobbin 316 at the time that the sling 20 is implanted is depicted inFIG. 20. At a later date, the external adjustment actuator 310 can beused to engage and rotate the bobbin 316 to either increase or decreasethe amount of the band or strand 330 taken up on the bobbin groove andto thereby shorten or extend, respectively, the adjustment spacing 162,164, and tighten or loosen, respectively, the sling 20 and increase ordecrease, respectively, tension applied by the sling central supportportion 40 to the urethra 58 (or anus).

As shown in FIG. 21, a minimum length of the adjustment spacing 162, 164is obtained by clockwise rotation of the bobbin 316 to move the catchend 324 out of detent 334 and along the outer edge of the bobbin 316until the catch end engages detent 336. As shown in FIG. 22, a maximumlength of the adjustment spacing 162, 164 is obtained bycounter-clockwise rotation of the bobbin 316 to move the catch end 324out of detent 334 and along the outer edge of the bobbin 316 until thecatch end engages detent 332.

An alternative detent arrangement of the bobbin and housing is depictedin FIG. 23. In this variation, the housing 340 supports a rotatablebobbin 346 surrounded by a fixed detent ring 342. The actuator-engagingreceptacle 348 is shaped to receive an actuator end shaped like athree-sided Keith needle. A first band or strand 350 extends from afixed end about a portion of the circumference of the bobbin 346 and iscoupled at its other end to the intermediate end 36, 46 of the sling 20formed of mesh 30. A second band or strand 352 extends from a fixed endabout a portion of the circumference of the bobbin 346 and is coupled atits other end to the intermediate end 38, 48 of the sling 20. Therotatable bobbin 346 and fixed detent ring 342 further comprise aplurality of flexible tabs or teeth that interlock like gear teeth.

Again, a neutral position of the bobbin 346 is established at the timethat the sling 20 is implanted is depicted. At a later date, the Keithneedle style external adjustment actuator 310 can be used to engage thereceptacle 348 and rotate the bobbin 346 clockwise to decrease orcounterclockwise to increase the amount of the bands or strands 350, 352taken up on the bobbin grooves. The clockwise and counterclockwisebobbin rotations thereby extend or shorten, respectively, the adjustmentspacing 162, 164, and loosen or tighten, respectively, the sling 20 anddecrease or increase, respectively, tension applied by the sling centralsupport portion 40 to the urethra 58.

An alternative dual cam adjustment mechanism 362, 364 is depicted inFIGS. 24, 25A-25D, and 26A-26D disposed in the adjustable spacings 162,164. The tension adjustment mechanisms 362, 364 each comprise a dual camassembly 370 comprising a first cam 372 coupled to first tether 374 anda first cam follower 376 and a second cam 382 coupled to a second tether384 and second cam follower 386. The ends of the first and secondtethers 374 and 384 are coupled to the sling intermediate ends 36, 46,and 38, 48 respectively. The first cam 372 rotated with respect to camfollower 376 operates to decrease the adjustable spacings 162, 164 fromthe neutral length of FIG. 24 to the contracted length of FIG. 25A asshown in FIGS. 25B-25D. The second cam 382 rotated with respect to camfollower 38 operates to increase the adjustable spacings 162, 164 fromthe neutral length of FIG. 24 to the contracted length of FIG. 26A asshown in FIGS. 26B-26D. The external adjustment actuator 310 (FIG. 18)is operated to engage either the first or the second cam 372 or 382 toincrease or decrease sling tension, respectively. Any suitable socketand actuator configuration may be employed for effecting selectiverotation of the cams.

In yet further embodiments of the second category depicted schematicallyin FIG. 27, the external adjustment actuator is a syringe 410 or thelike that is inserted percutaneously through a skin incision to engage aport 406, 408 of a fluid retaining chamber of the sling tensionadjustment mechanism 402, 404.

In the embodiment depicted in FIGS. 28-31, the port 406, 408 comprises apenetrable, resealable septum, and a needle stop may be included withinthe fluid chamber opposite the resealable septum to prevent needleperforation of the wall of the fluid retaining chamber within the outerhousing 415. The port 406, 408 is coupled to sling intermediate end 36,46, and a rod 420 is coupled at its free end to the sling intermediateend 38, 48. The port 406, 408 accesses a cylinder within housing 422 sothat the fluid delivered through the septum of the port 406, 408 is alsodelivered into the cylinder. A piston coupled to the rod 420 (which maysimply be an enlarged diameter end of rod 420) is also enclosed withinthe cylinder of housing 422. Rod 420 extends through a C-shaped opening417 in the end of outer housing 415 that guides but does not inhibitmovement of rod 420. The adjustment spacing 162, 164 is adjusted byinjecting or withdrawing fluid from the fluid chamber to laterallyextend or retract the piston mounted rod 420 to increase or decrease theadjustment spacing 162, 164 as shown in FIGS. 29-31.

A variation on this embodiment is depicted in FIGS. 32-36, wherein asling tension adjustment mechanism 432, 434 is substituted for the slingtension adjustment mechanism 402, 404 of FIGS. 27-31. In this variation,the port 436 is formed with a syringe needle interlock 443, and thesyringe 410 has a special interlocking tip 442 that opens and enters theinterlock 443 to deliver or withdraw fluid from or to the syringechamber 416. The port 436 is coupled to a housing 446 enclosing acylinder or fluid chamber 444 that the fluid is delivered into. Theinterlock 443 is spring loaded by spring 440 within the port chamber445. A piston 448 is also enclosed within the housing 446 and coupled toa rod 450 extending from the housing end. The port 436 is coupled tosling intermediate end 36, 46, and the rod 450 is coupled at its freeend to the sling intermediate end 38, 48.

The volume of fluid delivered into the fluid chamber 444 dictates theposition of the cylinder 448 within the chamber 444 and the extension ofthe rod 450. The adjustment spacing 162, 164 is therefore adjusted byinjecting or withdrawing fluid from the fluid chamber 444 to laterallyextend or retract the piston 448 and rod 450 to increase or decrease theadjustment spacing 162, 164 as shown in FIGS. 35-36.

The sling tension adjustment mechanisms 402, 404 and 432, 434 depictedin FIGS. 27-36 comprise single action, hydraulic pistons, wherein thefixed housing is coupled to one sling intermediate end and the movablerod end is coupled to the other intermediate sling end. It will beunderstood that the sling tension adjustment mechanisms 402, 404 and432, 434 depicted in FIGS. 27-36 may be modified to function as dualaction, hydraulic pistons having axially aligned and opposed pistonscoupled to respective rods, and the rod free ends of each mechanismcoupled to the sling intermediate ends 36, 46 and 38, 48.

A still further variation on this embodiment of the second categoryillustrated in FIG. 27 is depicted in FIGS. 37-40, wherein a slingtension adjustment mechanism 462, 464 is substituted for the slingtension adjustment mechanism 402, 404 of FIGS. 27-31. In this dualaction variation, the external adjustment actuator is the syringe 410 orthe like that is inserted percutaneously through a skin incision toengage a port 406, 408 of a fluid chamber 470 of the sling tensionadjustment mechanism 462, 464. The port 406, 408 comprises a penetrable,resealable septum, and a needle stop may be included within the fluidchamber opposite the resealable septum to prevent needle perforation ofthe wall of the fluid chamber 470.

The S-shaped chamber housing 472 enclosing the fluid chamber 470 isshaped with opposed spiral arms 466 and 468 respectively coupled tosling intermediate end 36, 46 and end 38, 48. The housing 472 is formedof a material that is expandable as fluid volume and pressure increasesas shown in FIG. 39 and contractible as fluid volume and pressuredecreases as shown in FIG. 40. The adjustment spacing 162, 164 istherefore adjusted by injecting or withdrawing fluid from the fluidchamber 470 to laterally extend or retract the opposed spiral arms 466and 468 to increase or decrease the adjustment spacing 162, 164 as shownin FIGS. 37-40.

In a further alternative variation (not shown), the arms 466 and 468 maybe corrugated with one or more corrugation to function in the manner ofbellows. In such case, the arms 466 and 468 may be spiral as depicted orextend in axial alignment and away from one another to increase ordecrease the adjustable spacing 162, 164.

In certain further embodiments of the second category of the inventiondepicted schematically in FIG. 41, the sling tension adjustmentmechanisms 502 and 504 comprise fluid reservoirs 512 and 514, housings522 and 524, respectively, and tubes 532 and 534 extending between thefluid reservoirs 512 and 514 and housings 522 and 524, respectively,alongside the sling end portions 42 and 44, respectively. The housings522 and 524 are coupled to the sling intermediate ends 36, 38 and 46,48, respectively, and define the adjustment spacings 162 and 164,respectively.

The fluid reservoirs 512 and 514 are adapted to be implanted just belowthe skin 52 adjacent the skin incisions 82 and 84, respectively.Alternatively, the tubes 532 and 534 may extend through the skinincisions 82 and 84 to dispose the fluid reservoirs 512 and 514 outsidethe skin during the healing phase. In that case, the tubes 532 and 534may be pulled upon to detach their distal ends from tube fittings on thehousings 522 and 524 after tissue ingrowth into the mesh pores hassecured the sling 20 in position. Tissue ingrowth should maintain theadjustment spacings 162, 164 even if the hydraulic fluid (saline) thenescapes from fluid cylinders and chambers within the housings 522 and524.

The fluid reservoirs 512 and 514 have respective fluiddelivery/withdrawal ports 516 and 518 that may be percutaneouslyaccessed by needle tip 412 of syringe 410 to introduce fluid into thefluid reservoir 512, 514 or to withdraw fluid from the fluid reservoir512, 514 following implantation of the sling 20 to thereby adjust theamount of fluid in the fluid chambers of housings 522 and 524 and adjustthe length of the adjustable spacings 162 and 164.

It will be understood that the housings 522, 524 may incorporate any ofthe adjustment mechanisms 402, 404 or 432, 434 or 462, 464 andvariations thereof described above with the tubes 532, 534 and fluidreservoirs 512 and 514 substituted for the above-described fluiddelivery/withdrawal ports.

In FIGS. 42-45, alternative forms of adjustment housings 522 and 524 ofthe adjustment mechanisms 502, 504 and 502′, 504′ containing fluidchambers, pistons, and connecting rods are depicted in greater detail.The housing 522, 524 encloses a fluid chamber 526, a piston 528 and arod 530 extending axially from one end of the housing 522, 524. In theparticular single action cylinder designs depicted in FIGS. 42-45, thehousing 522, 524 is elliptical in lateral cross-section having a majorellipse axis corresponding generally to the width of the mesh 30 ofsling 20 so that the minor ellipse axis minimizes overall thickness ofthe sling 20. The housing wall 542, fluid chamber 526, and piston 528may be shaped more oblong than elliptic as shown in FIG. 46. The slingintermediate end 36, 46 is coupled by thermoplastic rivets or sutures orthe like to the stationary end of housing 522, 524, and the slingintermediate end 38, 48 is coupled by thermoplastic rivets or sutures orthe like to the movable free end of rod 530 in each housing 522, 524. Itwill be understood that the piston 528 is formed with a ring or ringsthat provide a tight seal with the housing wall 542 defining the fluidchamber 526 to minimize fluid loss.

In the variation of this embodiment of adjustment mechanism 502, 504depicted in FIGS. 42-44, the tubes 532 and 534 extend from the end ofthe housing 522, 524 opposite the rod 530 and centrally along the axesof the mesh 30 of each of the end portions 42 and 44, respectively, tothe fluid reservoirs 512 and 514, respectively, to supply fluid to orwithdraw fluid from the chamber portion defined by the housing interiorwall 536 and the piston head 538. In the variation of adjustmentmechanism 502′, 504′ depicted in FIG. 45, the tube 532, 534 extendsoffset from the axis of the sling mesh 30.

A dual action hydraulic cylinder form of an adjustment mechanism 552similar to adjustment mechanisms 502, 504 and 502′, 504′ is depicted inFIG. 46. An oblong shape of the piston 558, the housing 562, and fluidchamber 556 is also depicted in FIG. 46 that may be substituted for theelliptical shapes of the piston 528, housing 522, 524, and fluid chamber526, respectively, of FIGS. 42-45.

The dual action adjustment mechanism 552 requires two subcutaneouslyimplantable fluid reservoirs (not shown) or a dual action fluidreservoir and tubes 572 and 574 extending alongside the sling mesh tosubcutaneous implantation sites. The housing 562 encloses a fluidchamber 556, piston 558 and rod 560 extending through an opening in oneend of the housing 562. The fluid chamber 556 comprises a contractingchamber 568 coupled to tube 572 on one side of piston 558 and anextending chamber 570 coupled to tube 574 on the other side of thepiston 558.

In use, the adjustment mechanism 552 is substituted for the adjustmentmechanisms 502 and 504 of FIG. 41 to define the adjustment spacings 162and 164 as a function of the position of the piston 558 in the fluidchamber 556. The adjustment spacing 162, 164 is lengthened if fluid isintroduced into chamber portion 570 from the first fluid reservoirthrough tube 574 while fluid is simultaneously withdrawn from chamberportion 568 into the second fluid reservoir through tube 572.Conversely, adjustment spacing 162, 164 is shortened if fluid isintroduced into chamber portion 568 from the second fluid reservoirthrough tube 572 while fluid is simultaneously withdrawn from chamberportion 570 into the first fluid reservoir through tube 574.

Any of the above-described single action hydraulic adjustment mechanismscan be modified in this fashion to function as a dual action hydraulicadjustment mechanism. It may be desirable to provide a locking mechanismto maintain the adjusted position of the piston and rod of the single ordual action hydraulic adjustment mechanisms disclosed herein aftersetting the adjustment spacing. Leakage and blow-by of the pressurizedhydraulic fluid may occur causing the adjustment spacing to changebefore tissue ingrowth into the sling mesh pores stabilizes the sling.

FIGS. 47 and 48 illustrate one form of locking mechanism 405incorporated into a single action hydraulic cylinder adjustmentmechanism 402, 404 of the type shown in FIGS. 28-31. In the depictedsingle action, hydraulic cylinder, adjustment mechanism 402′, 404′,upper and lower lines of serrations or teeth 421 and 423 extend alongthe rod 420. The rod 420 extends from the cylinder 455 within housing422 and passes through a locking ring 425 mounted to slightly rock orpivot on axle 427 supported by the outer housing 415. A counterweightrod 429 also extends from the axle within the outer housing 415.Serrations or teeth are also formed on the inner wall of the lockingring 425 in alignment and engagement with the upper and lower lines ofserrations or teeth 421 and 423.

The frictional engagement of the serrations of the locking ring 425 andthe upper and lower lines of serrations or teeth 421 and 423 function asthe locking mechanism 405 and tend to inhibit movement of the rod 420,but the engagement force is overcome when fluid is added to or removedfrom the cylinder. The piston and rod 420 can therefore move between itslimits due to the change in fluid pressure. If fluid pressure graduallydecreases due to leakage, the counterweight rod 429 tends to cause thelocking ring 425 to pivot on axle 427 to engage the teeth together toresist movement of the rod 420. It will be understood that the outerhousing 415 may extend completely around the locking ring 425 and thehousing 422 to isolate them from body tissue.

FIGS. 49 and 50 illustrate another form of locking mechanism 435incorporated into a single action hydraulic cylinder adjustmentmechanism 402, 404 of the type shown in FIGS. 28-31. In the depictedsingle action hydraulic cylinder adjustment mechanism 402″, 404″, thelocking mechanism 435 comprises modifications to the rod 420 providingreduced diameter sections 437, 439, and a laterally extending pin 441, apair of springs 447, 449 disposed around rod sections 437, 439, and arotatable sleeve 457 disposed over the rod 420. The rotatable sleeve 457surrounding rod 420 extends through the C-shaped opening 417 in housing415. A spiral slot 451 with a plurality of notches 453 is formed in therotatable sleeve 457, and the pin 441 extends through the spiral slot451 and can be engaged in a notch 453.

The adjustment spacing 162, 164 is adjusted by injecting or withdrawingfluid from the fluid chamber to laterally extend or retract the pistonmounted rod 420 to increase or decrease the adjustment spacing 162, 164.In the process, rod 420 is moved within cylinder 455 against the springforce of one or the other of the springs 447, 449 and the outwardlyextending pin 441 travels along the spiral slot 447, rotating the sleeve457. The spring force functions as a detent by lodging the pin 441 intoengagement with the closest notch 453. The engagement resists any changein rod position that might otherwise occur due to loss of fluid from thecylinder. However, the engagement force can be overcome when fluid isadded to or removed from the cylinder. It will be understood that theouter housing 415 may extend completely around the pin 441 and thehousing 422 to isolate them from body tissue.

These locking mechanisms may be incorporated into the various single anddual action hydraulic cylinder adjustment mechanisms disclosed herein.

A further miniaturized single action hydraulic cylinder adjustmentmechanism 402″, 404″ is depicted in FIGS. 51-53 that may be substitutedfor the above-described adjustment mechanism 502, 504 of FIG. 41. Inthis embodiment, the width and height or diameter of the modifiedhousing 415′ is sized to correspond generally to the width of the slingmesh 30 of sling 20. The locking mechanism 405 described above isincorporated into the modified housing 415′ although locking mechanism435 may be substituted for locking mechanism 405. The cylinder 455 isdirectly coupled to a tube coupling 419 that the end of the tube 532,534 is affixed to. The syringe 410 is employed to penetrate the septumof the fill port 512, 514 to add or remove fluid from cylinder 455 andadjust the rod 420 to adjust the adjustable spacing as described abovewith respect to FIG. 41. As noted above, the tube distal end may bedetached from the fluid coupling 419 when tissue ingrowth immobilizesthe sling mesh 30. It will be understood that the outer housing 415′ mayextend completely around the locking ring 425 and the housing 422′ toisolate them from body tissue.

The adjustable mechanism of the second aspect of the sling 20 of thepresent invention may also comprise miniaturized mechanical mechanismsthat are adjustable outside the patient's skin or percutaneously throughthe patient's skin during the healing phase. In certain embodiments theexternal adjustment actuator comprises an elongated gear driveinstrument having a shaft extending between a handle and an engaging endshaped to be percutaneously advanced through the skin. The adjustmentmechanism comprises a driven gear means engageable by the engaging endthe gear drive for operating the spacing adjustment means to increase ordecrease the adjustment spacing.

A miniaturized gear driven adjustment mechanism 802, 804 is depicted inFIGS. 54 and 55 that may be substituted for the above-describedadjustment mechanisms 502 and 504 of FIG. 41. An adjustment mechanismhousing 822 is attached at one end to the intermediate sling end 36, 46and encloses a gear chamber 826 and a rod chamber 824. A driven gear 828is enclosed within the gear chamber 826, and a rod 820 having a spiralthread 834 extending around its circumference extends through the rodchamber 824 and out of housing end opening 832. The spiral thread 834engages gear threads within the bore of the driven gear 828. One end ofthe rod 820 is coupled to the intermediate sling end 38, 48.

A gear drive 810 comprises an elongated drive shaft 812 extendingthrough a sheath lumen 814 of a drive sheath 816 to a drive gear 830within the gear chamber 826 of an outer housing 822. The teeth of thedrive gear 830 and the driven gear 828 are in engagement. The drivesheath 816 extends through the skin incisions following implantation toenable adjustment of the length of the rod 820 within the rod chamber824. The gear drive handle 818 may be grasped and rotated to rotate thedrive shaft 812 and the drive gear 830. Rotation of the driven gear 828around the rod 820 in one direction drives the rod 820 out of the rodchamber 824 and lengthens the adjustment spacing 164, 166, whereasrotation of the driven gear 828 around the rod 820 in the otherdirection drives the rod 820 into the rod chamber 824 and shortens theadjustment spacing 164, 166.

The distal end of drive shaft 812 may be shaped to detachably engageaxially with the drive gear 830 so that the drive sheath 816 and shaft812 may be axially pulled upon from their proximal ends outside the skinto detach from the housing 822 and drive gear 830, respectively, and bedrawn out through the skin incision after tissue ingrowth into the meshpores has secured the sling 20 in position.

An alternative, miniaturized, gear driven adjustment mechanism 852, 854is depicted in FIG. 56 that may be substituted for the above-describedadjustment mechanisms 302 and 304 of FIG. 18. An adjustment mechanismhousing 872 is attached at one end to the intermediate sling end 36, 46and encloses a gear chamber 876 and a rod chamber 874. A driven gear 878is enclosed within the gear chamber 876, and a rod 870 having a spiralthread 884 extending around its circumference extends through the rodchamber 874 and out of housing end opening 832. The spiral thread 884engages gear threads within the bore of the driven gear 878. One end ofthe rod 870 is coupled to the intermediate sling end 38, 48.

A gear driver 860 comprises an elongated drive shaft 866 having a spiraldrive gear 880 at the distal end of the drive shaft 866 and a handle 868at the proximal end of the drive shaft 866. The distal end of the geardrive 860 may be shaped to be percutaneously advanced through thepatient's intact skin at pre-made incisions to interact with the drivengear 878. The distal end of the drive shaft 866 is extended through anopening in the housing 872 and into engagement with the drive gear 880to adjust of the length of the rod 870 within the rod chamber 874. Theteeth of the drive gear 880 and the driven gear 878 are depicted inengagement in FIG. 56. The gear drive handle 868 may be grasped androtated to rotate the drive shaft 866 and the drive gear 880. Rotationof the driven gear 878 around the rod 870 in one direction drives therod 870 out of the rod chamber 874 and lengthens the adjustment spacing164, 166, whereas rotation of the driven gear 878 around the rod 870 inthe other direction drives the rod 870 into the rod chamber 874 andshortens the adjustment spacing 164, 166.

It will be understood that alternatively, the gear drive may take theform of gear drive 810 of FIG. 54 that is temporarily left extendingthrough the skin incisions following implantation of the sling. In thatcase, the distal end of drive shaft 812 may be shaped to detachablyengage axially with the drive gear 880 so that the drive sheath 816 andshaft 812 may be axially pulled upon from their proximal ends outsidethe skin to detach from the housing 872 and drive gear 880,respectively, and be drawn out through the skin incision after tissueingrowth into the mesh pores has secured the sling 20 in position.

A still further alternative, miniaturized, mechanical drive mechanism902, 904 is depicted in FIG. 57 that may be substituted for theabove-described adjustment mechanisms 502 and 504 of FIG. 41. In thisembodiment, the adjustment spacing 164, 166 is adjusted by a rack andpinion gear drive 910 extended temporarily through the patient's skin orimplanted under the patient's skin and accessed percutaneously with anexternal adjustment actuator 310 shaped to engage the pinion gear drive910 similar to external adjustment actuator 310 shown in FIG. 18.

In the embodiment depicted in FIG. 57, the gear drive 910 comprises anelongated drive shaft 912 extending through a sheath lumen 914 of adrive sheath 916 from a gear drive housing 918 to the mechanical drivemechanism 902, 904. The proximal end of the sheath 916 is coupled to thegear drive housing 918. The gear drive housing 918 encloses a gearchamber 926 in which a rack 930, coupled at one end to the proximal endof the drive shaft 912, is disposed for lateral movement, and a pinion928 is positioned for rotary movement. The teeth of the rack 930 and thepinion 928 are in engagement. A hex shaped recess 932 is formed in thepinion to be engaged by a hex wrench to rotate the pinion 928 andlaterally move the rack 930 within the gear chamber 926.

The distal ends of the sheath 916 and the drive shaft 912 are coupled toone end of the housing 906 of the drive mechanism 902, 904. The housing906 takes the form of the housing 415′ of FIGS. 51-53 and is depictedwithout a cover to expose the rod chamber 908 and the rod 920 andlocking mechanism 905 disposed therein. Locking mechanism 905corresponds to locking mechanism 405 described above and may take otherforms or may not be provided in this embodiment.

Rotation of the pinion 928 in one direction drives the rack 930 and thedrive shaft 912 in one direction to drive rod 920 out of the rod chamber908 and lengthen the adjustment spacing 164, 166. Rotation of the pinion928 in the other direction drives the rack 930 and the drive shaft 912in the other direction to pull rod 920 into the rod chamber 908 andshortens the adjustment spacing 164, 166.

A still further alternative, miniaturized, mechanical drive mechanism952, 954 is depicted in FIGS. 58A-58D that may be substituted for theabove-described adjustment mechanisms 502 and 504 of FIG. 41. In thisembodiment, the adjustment spacing 164, 166 is also adjusted by a rackand pinion gear drive 910 extended temporarily through the patient'sskin or implanted under the patient's skin and accessed percutaneouslywith an external adjustment actuator 310 shaped to engage the rack andpinion gear drive 910 as described above with respect to FIG. 57.

In this embodiment, the housing 956 is coupled at one end to the slingintermediate end 36, 46, and encloses a rack chamber 958 and a drivenrack 962 within the rack chamber 958. The driven rack 962 in rackchamber 958 is coupled at one rack end to the end of the drive shaft 914and at the other rack end to the sling intermediate end 38, 48. Apivotally mounted catch 964 is shaped to engage rack teeth 962 and toguide movement and help maintain rack 960 in a selected position in therack chamber 958 to define the adjustment spacing 162, 164.

Rotation of the pinion 928 in one direction drives the drive rack 930and the drive shaft 912 in one direction to move drive rack 962 out ofthe rack chamber 958 and lengthen the adjustment spacing 164, 166 asshown in FIG. 58B. Rotation of the pinion 928 in the other directionmoves the rack 930 and the drive shaft 912 in the other direction topull rod 920 into the rack chamber 958 and shortens the adjustmentspacing 164, 166, as shown in FIG. 58D.

It will be understood that the gear drive housing 918 can be implantedunder the skin. It will also be understood that each gear drive housing918 can be temporarily left extending through the skin incisionsfollowing implantation of the sling. In this case, the distal end ofdrive shaft 912 may be shaped to detachably engage axially with the rod920, and the distal end of the sheath 916 may detachably engage with theend of the housing 906 or 956. After tissue ingrowth into the mesh poreshas secured the sling 20 in position, the drive sheath 916 and shaft 912may be axially pulled upon from their proximal ends outside the skin todetach from the housing 906 or 956 and rod 920 or rack 960,respectively, and be drawn out through the skin incision.

With respect to the embodiment of FIGS. 58A-58D, it will be understoodthat the drive pinion 928 can alternatively be integrated into the rackchamber 958 in lieu of or alongside the pivoting catch 964. In thisvariation, the gear drive 910, sheath 916, and the shaft 912 would beeliminated, and the pinion 928 located if the rack chamber 958 could beaccessed by the percutaneously inserted hex wrench 310 in the mannerdescribed above with respect to FIGS. 18-23.

It will be understood that the above-described embodiments of the secondcategory of the sling of the invention may be modified by substitutingother support materials than open pore mesh 30, particularly in thecentral support portion 40, e.g., homograft or allograft materials ornonporous synthetic materials. Moreover, other materials and structuresmay be substituted for the mesh 30 in the sections of constituting oneor both of the end portions extending from the intermediate ends 38 and48 to the ends of the central support portion 40. For example, one ormore straight or spiral suture may be substituted for all or part ofsuch sections.

While the above-described embodiments of adjustable tension slingsdepict methods and apparatus for adjusting sling tension in each endportion, it will be understood that in each case only one adjustmentmechanism may be provided acting on or within one sling end portion (oralternatively on both end portions 1).

It will also be understood that all of the above-described embodimentsof the urethral or fecal slings may optionally incorporate a slingcentral portion adjustment mechanism, e.g., suture 108 illustrated inFIGS. 10 and 11 or as otherwise described herein.

Furthermore, it will be understood that all of the above-describedembodiments of the urethral or fecal slings illustrated in FIGS. 12through 58 may optionally incorporate tissue anchors coupled to thesling ends extending from or incorporated into the sling ends 32 and 34.For example the sling anchor 92 illustrated extending from sling end 32in FIG. 11 could be incorporated into a suture extending from the slingends 32 and 34 in each such embodiment to assist in tensioning the slingend portions 42 and 44 during adjustment of the tension adjustmentmechanisms.

Many of the embodiments described herein can be used in connection withprolapse and pelvic floor repairs (men and women) that may requirepost-operative adjustment of the implanted mesh or graft or sling. Theymay also be used in connection with prostatectomies or hysterectomiesand to support any other body tissue within the pelvic area or otherparts of the body including but not limited to, hernia repair, andshoulder and abdominal repairs. Examples of meshes, grafts and prolapserepairs are described in U.S. Publication Nos. 2004-0039453 A1,2005-0250977 A1, and 2005-0245787 A1, which are hereby incorporated byreference in their entirety.

All patents and publications referenced herein are hereby incorporatedby reference in their entireties.

It will be understood that certain of the above-described structures,functions and operations of the above-described preferred embodimentsare not necessary to practice the present invention and are included inthe description simply for completeness of an exemplary embodiment orembodiments. It will also be understood that there may be otherstructures, functions and operations ancillary to the typical surgicalprocedures that are not disclosed and are not necessary to the practiceof the present invention.

In addition, it will be understood that specifically describedstructures, functions and operations set forth in the above-referencedpatents can be practiced in conjunction with the present invention, butthey are not essential to its practice. It is therefore to beunderstood, that within the scope of the appended claims, the inventionmay be practiced otherwise than as specifically described withoutactually departing from the spirit and scope of the present invention.

1. A system for providing support to body tissue to alleviateincontinence comprising: an elongated incontinence sling having acentral support portion adapted to be positioned to support any one ofthe urethra or anus having first and second sling end portions extendingfrom the central support portion through body tissue; a tensionadjustment mechanism acting on or within one or both of the sling endportions, wherein the sling tension adjustment mechanism is attached toand extends through an adjustment spacing between sling intermediateends within the sling end portion intermediate the sling end and thesling central portion and comprises spacing adjustment means forchanging the adjustment spacing; and external adjustment actuator meansfor actuating the sling tension adjustment mechanism to change theadjustment spacing between the sling intermediate ends and therebychange tension in the sling central portion applied to the urethra oranus.
 2. The system of claim 1, wherein the external adjustment actuatormeans extends through the patient's skin for adjustment.
 3. The systemof claim 1, further comprising at least one tissue anchor coupled to atleast one sling end adapted to be passed through body tissue to anchorthe sling end against the body tissue to stabilize the sling end andfacilitate adjustment of sling tension.
 4. The system of claim 1,wherein: the tension adjustment mechanism comprises a portion of asuture extending across the adjustment spacing between the slingintermediate ends within the sling end portion intermediate the slingend and the sling central portion to form the spacing adjustment means;and the external adjustment actuator means comprises a portion of thesuture extending from the spacing adjustment means between the slingintermediate ends and adapted to be extended through a skin incision formanipulation to change the adjustment spacing between the slingintermediate ends and thereby change tension in the sling centralportion applied to the urethra or anus.
 5. The system of claim 1,wherein: the sling tension adjustment mechanism comprises a portion of asuture extending the across the adjustment spacing between the slingintermediate ends within the sling end portion intermediate the slingend and the sling central portion to form the spacing adjustment means;and the external adjustment actuator means comprises: a portion of thesuture extending from the spacing adjustment means between the slingintermediate ends and adapted to be extended through a tissue pathwaythrough body tissue; and a tissue anchor having a bore receiving theportion of the suture extending through body tissue, the tissue anchoradapted to be manipulated to anchor against the body tissue and to thechange the adjustment spacing between the sling intermediate ends andthereby change tension in the sling central portion applied to theurethra or anus.
 6. The system of claim 5, wherein the sling furthercomprises at least one tissue anchor coupled to at least one sling endadapted to be passed through body tissue to anchor the sling end againstthe body tissue to stabilize the sling end and facilitate adjustment ofsling tension.
 7. The system of claim 1, wherein: the externaladjustment actuator comprises a transmitter adapted to be brought intoproximity to or applied against the skin and operated to generate aspacing adjustment command that is communicated transcutaneously throughthe skin and body tissue to the adjustment mechanism; and the adjustmentmechanism comprises means responsive to the transcutaneouslycommunicated commands for operating the spacing adjustment means toincrease or decrease the adjustment spacing.
 8. The system of claim 7,wherein: the external adjustment actuator comprises a RF signaltransmitter that is employed to generate a RF sling adjustment commandtransmitted through the patient's skin; and the adjustment mechanismcomprises a RF receiver for receiving the transmitted commands, and thespacing adjustment means is responsive to the received RF signal toincrease or decrease the adjustment spacing.
 9. The system of claim 7,wherein: the external adjustment actuator comprises is a magnetic fieldgenerator or permanent magnet that is employed to generate a magneticfield representing a sling adjustment command that passestranscutaneously through the patient's skin; and the spacing adjustmentmeans comprises a magnetic field responsive element that responds to themagnetic field by increasing or decreasing the adjustment spacing. 10.The system of claim 7, wherein: the external adjustment actuatorcomprises an external thermal heater or cooler adapted to be applied tothe patient's skin; and the spacing adjustment means comprises atemperature responsive element responsive to heat or cold appliedtranscutaneously through the patient's skin to heat or cool theadjustment mechanism to thereby increase or decrease the adjustmentspacing.
 11. The system of claim 7, wherein: the external adjustmentactuator comprises an external light source adapted to be applied to thepatient's skin and to generated a light wavelength that is transmittablethrough skin and body tissue; and the spacing adjustment means compriseslight responsive elements responsive to the wavelength of lightgenerated by the external adjustment actuator and transmittedtranscutaneously to the sling tension adjustment mechanism to therebyincrease or decrease the adjustment spacing.
 12. The system of claim 1,wherein: the external adjustment actuator comprises an elongatedinstrument having a shaft extending between a handle and an engaging endshaped to be percutaneously advanced through the skin; and theadjustment mechanism comprises means engageable by the engaging end theexternal adjustment actuator for operating the spacing adjustment meansto increase or decrease the adjustment spacing.
 13. The system of claim12, wherein: the engageable means comprises: a housing coupled to onesling intermediate end; and a rotatable bobbin supported by the housinghaving a receptacle shaped to receive the engaging end of the elongatedinstrument to enable rotation of the bobbin; and the spacing adjustmentmeans comprises a strand coupled to the other sling intermediate end andextending around the bobbin that is adapted to be wound onto the bobbinto decrease the adjustment spacing or to be unwound from the bobbin toincrease the adjustment spacing.
 14. The system of claim 12, wherein:the engageable means comprises: a housing having a chamber bounded by afixed detent ring of tabs extending into the chamber; and a rotatablebobbin supported by the housing within the chamber having a receptacleshaped to receive the engaging end of the elongated instrument to enablerotation of the bobbin and an array of flexible tabs extending radiallyoutward of the bobbin in engagement with the tabs of the fixed detentring; and the spacing adjustment means comprises a first strand coupledto the first sling intermediate end and extending around the bobbin in afirst direction and a second strand coupled to the second slingintermediate end and extending around the bobbin in an oppositedirection, whereby the first and second strands are wound onto thebobbin by rotation of the bobbin in a first direction to shorten theadjustment spacing and the first and second strands are unwound from thebobbin by rotation of the bobbin in a second direction to shorten theadjustment spacing.
 15. The system of claim 12, wherein: the engageablemeans comprises: a housing having a chamber; a dual cam assemblysupported by the housing within the chamber comprising a first camhaving a first receptacle shaped to receive the engaging end of theelongated instrument and a second cam having a second receptacle shapedto receive the engaging end of the elongated instrument; a first camfollower mounted to the housing and bearing on the first cam; and asecond cam follower mounted to the housing and bearing on the secondcam; and the spacing adjustment means comprises a first tether coupledto the first sling intermediate end and extending around the first camin a first direction and a second tether coupled to the second slingintermediate end and extending around the second cam in an oppositedirection, whereby the first tether is wound onto the first cam byrotation of the first cam in a first direction into engagement with thefirst cam follower to shorten the adjustment spacing and the secondtether is unwound from the second cam by rotation of the second cam inthe first direction into engagement with the second cam follower toshorten the adjustment spacing.
 16. The system of claim 1, wherein: theexternal adjustment actuator comprises a syringe having a syringechamber adapted to be filled with fluid and a syringe needle having aneedle bore extending from the syringe chamber to the needle tip, thesyringe needle adapted to be percutaneously passed through the patient'sskin; the tension adjustment mechanism comprises a housing enclosing afluid retaining chamber having a port penetrable by the syringe needletip enabling adding or withdrawing fluid from the fluid retainingchamber; and the spacing adjustment means is coupled to the fluidretaining chamber, whereby the adjustment spacing is adjusted by passingthe syringe needle tip through the port and injecting or withdrawingfluid from the fluid retaining chamber to increase or decrease theadjustment spacing.
 17. The system of claim 16, wherein: the housingcomprises a piston chamber, a piston within the chamber, and a pistonrod extending from the piston chamber; the housing is coupled to thefirst intermediate end; and the piston rod is coupled to the secondintermediate end, whereby the piston is moved within the piston chamberto increase the adjustment spacing upon adding fluid through the port tothe piston chamber and to decrease the adjustment spacing uponwithdrawing fluid through the port to the piston chamber.
 18. The systemof claim 16, wherein: the housing is formed of a flexible material inhaving opposed first and second spiral arms extending away from theport; the first intermediate end is coupled to the first spiral arm; andthe second intermediate end is coupled to the second spiral arm, wherebythe arcuate arms straighten to increase the adjustment spacing uponadding fluid through the port.
 19. The system of claim 1, furthercomprising a fluid reservoir adapted to be subcutaneously implantedhaving a penetrable port and enclosing a reservoir chamber and furthercomprising a tube extending from the reservoir chamber to a tube end;and wherein: the external adjustment actuator comprises a syringe havinga syringe chamber adapted to be filled with fluid and a syringe needlehaving a needle bore extending from the syringe chamber to the needletip, the syringe needle adapted to be percutaneously passed through thepatient's skin and through the port into the reservoir chamber; thetension adjustment mechanism comprises a housing enclosing a fluidretaining chamber coupled to the tube end; and the spacing adjustmentmeans is coupled to the fluid retaining chamber, whereby the adjustmentspacing is adjusted by passing the syringe needle tip through the portand injecting or withdrawing fluid from the reservoir chamber and thefluid retaining chamber to increase or decrease the adjustment spacing.20. The system of claim 19, wherein: the housing comprises a pistonchamber, a piston within the chamber, and a piston rod extending fromthe piston chamber; the housing is coupled to the first intermediateend; and the piston rod is coupled to the second intermediate end,whereby the piston is moved within the piston chamber to increase theadjustment spacing upon adding fluid through the port to the pistonchamber and to decrease the adjustment spacing upon withdrawing fluidthrough the port to the piston chamber.
 21. The system of claim 20,wherein the fluid retaining chamber comprises a single action hydrauliccylinder or a dual action hydraulic cylinder.
 22. The system of claim 1,wherein: the external adjustment actuator comprises an elongated geardrive instrument having a shaft extending between a handle and anengaging end shaped to be percutaneously advanced through the skin; andthe adjustment mechanism comprises a driven gear means engageable by theengaging end the gear drive for operating the spacing adjustment meansto increase or decrease the adjustment spacing.
 23. The system of claim22, wherein: the driven gear means comprises: a housing coupled to thefirst sling intermediate end enclosing a gear chamber and a rod chamber;a threaded rod extending through the rod chamber and attached at one endto the second sling intermediate end; and a rotatable driven gearsupported by the housing and in engagement with the threaded rod,whereby the driven gear is rotatable by engagement with and rotation ofthe drive gear in a first direction to extend the threaded rod from therod chamber to increase the adjustment spacing and is rotatable byengagement with and rotation of the drive gear in a second direction todraw the threaded rod into the rod chamber to decrease the adjustmentspacing.
 24. The system of claim 22, further comprising: a gear driveadapted to be subcutaneously implanted having a receptacle, and anelongated drive shaft extending through a sheath lumen of a drive sheathto a drive shaft end, and wherein: the external adjustment actuatorcomprises an elongated gear drive instrument having a shaft extendingbetween a handle and an engaging end shaped to be percutaneouslyadvanced through the skin into engagement with the receptacle; and theadjustment mechanism comprises a driven gear means engageable by thedrive shaft end for operating the spacing adjustment means to increaseor decrease the adjustment spacing.
 25. A method of providing support tobody tissue to alleviate incontinence comprising: providing an elongatedincontinence sling having a central support portion adapted to bepositioned to support any one of the urethra or anus having first andsecond sling end portions extending from the central support portionthrough body tissue and a tension adjustment mechanism acting on orwithin one or both of the sling end portions, wherein the sling tensionadjustment mechanism is attached to and extends through an adjustmentspacing between sling intermediate ends within the sling end portionintermediate the sling end and the sling central portion and comprisesspacing adjustment means for changing the adjustment spacing; implantingthe incontinence sling disposing the central support portion inoperative relation to the one of the urethra or anus; and actuating thesling tension adjustment mechanism to change the adjustment spacingbetween the sling intermediate ends and thereby change tension in thesling central portion applied to the urethra or anus.